Residual Replication of HIV-1 in the Gut Associated Lymphoid Tissue (GALT) of Patients on Highly Active Antiretroviral Therapy (HAART): the ANRS EP 44 Study

This study has been completed.
Sponsor:
Information provided by:
French National Agency for Research on AIDS and Viral Hepatitis
ClinicalTrials.gov Identifier:
NCT01038401
First received: December 22, 2009
Last updated: July 13, 2010
Last verified: July 2010
  Purpose

HIV-1 cannot be eradicated from infected individuals by current antiretroviral regimens. Cellular reservoirs and tissue sanctuary sites allow latent HIV-1 persistence and ongoing low-level virus replication. This project aims to characterize the residual replication of HIV-1 in subjects on antiretroviral therapy, particularly in the gut-associated lymphoid tissue.


Condition Intervention
HIV Infection
Procedure: GI endoscopy and GALT biopsies
Biological: A sample of venous blood will also be collected

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Characterization of the Residual Replication of HIV-1 in the Gut-associated Lymphoid Tissue in Patients Receiving Effective Highly Active Antiretroviral Therapy: the ANRS EP 44 Study

Resource links provided by NLM:


Further study details as provided by French National Agency for Research on AIDS and Viral Hepatitis:

Primary Outcome Measures:
  • Correlation between HIV-1 viral load and CD4+ T lymphopenia in the GALT. [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • HIV-1 DNA load in the GALT vs blood CD4+ T cells [ Designated as safety issue: No ]
  • HIV-1 tropism in the GALT vs blood CD4+ T cells [ Designated as safety issue: No ]
  • Characterization of residual HIV-1 in the plasma < 40 copies/ml [ Designated as safety issue: No ]
  • Characterization of HIV-1 DNA in blood monocytes [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: September 2008
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
HIV-1-infected patients on effective HAART Procedure: GI endoscopy and GALT biopsies
This project aims to characterize the residual replication of HIV-1 in subjects on HAART, particularly in the gut-associated lymphoid tissue (GALT)
Biological: A sample of venous blood will also be collected
These samples of blood will be use to characterize the residual viral populations on effective HAART in three compartments, plasma, monocytes, and GALT
Non Infected HIV Volunteers Procedure: GI endoscopy and GALT biopsies
This project aims to characterize the residual replication of HIV-1 in subjects on HAART, particularly in the gut-associated lymphoid tissue (GALT)
Biological: A sample of venous blood will also be collected
These samples of blood will be use to characterize the residual viral populations on effective HAART in three compartments, plasma, monocytes, and GALT

Detailed Description:

Highly active antiretroviral therapy (HAART) successfully controls HIV-1 replication in most individuals, resulting in substantial immune restoration and decreased morbidity and mortality. However HIV-1 cannot be eradicated from infected individuals by current regimens. Cellular reservoirs and tissue sanctuary sites allow latent HIV-1 persistence and ongoing low-level virus replication, despite maximum virus suppression on HAART. This project aims to characterize the residual replication of HIV-1 in subjects on HAART, particularly in the gut-associated lymphoid tissue (GALT). A group of 20 HIV-1-infected patients on effective HAART will undergo GI endoscopy and GALT biopsies will be taken. A sample of venous blood will also be collected. These samples will be use to characterize the residual viral populations on effective HAART in three compartments, plasma, monocytes, and GALT. HIV-1 coreceptor usage and its evolution on HAART will be characterized in virus reservoirs. This project could provide further insights into the residual replication of HIV-1 in subjects receiving HAART.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • HIV-1 infection (ELISA and western-blot tests)
  • Continuous antiretroviral therapy >= 12 months
  • Plasma HIV-1 RNA =< 40 copies/ml >= 6 months
  • Indication of gastro-intestinal endoscopy
  • Age >= 18-year old
  • Physical examination
  • Informed consent

Exclusion Criteria:

  • Plasma HIV-1 RNA > 40 copies/ml in the last 6 months
  • Involvement in a HIV vaccine study
  • Treatment with interferon-alpha or PEG- interferon-alpha in the last 6 months
  • Treatment with interleukin-2 in the last 6 months
  • Decompensated cirrhosis
  • Abnormal hemostasis tests
  • Inflammatory bowel disease ; coeliac disease
  • Lymphoma
  • Blood transfusion in the last 6 months
  • Absence of social security (health insurance)
  • Pregnant or breastfeeding woman
  • Incapable adult
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01038401

Locations
France
ANRS center from Toulouse
Toulouse, France
Sponsors and Collaborators
French National Agency for Research on AIDS and Viral Hepatitis
Investigators
Principal Investigator: MASSIP Patrice CHU Toulouse
  More Information

Additional Information:
No publications provided

Responsible Party: Lucie Marchand/Project manager, French National Agency for Research on AIDS and Viral Hepatitis
ClinicalTrials.gov Identifier: NCT01038401     History of Changes
Other Study ID Numbers: 2008-A00239-46
Study First Received: December 22, 2009
Last Updated: July 13, 2010
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by French National Agency for Research on AIDS and Viral Hepatitis:
HIV infection
HAART
Viral DNA test positive-10063306
Blood HIV RNA 10049826
Treatment Experienced

Additional relevant MeSH terms:
Infection
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on October 01, 2014